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Everolimus in CDK12-Deficient Metastatic Colorectal Cancer (EVER-RECODE)

NCT07435584 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2026-02-27

No results posted yet for this study

Summary

This is a prospective, open-label, multicenter, single-arm Phase Ib/II study evaluating the safety and preliminary efficacy of everolimus in patients with CDK12-deficient refractory metastatic colorectal cancer.

Conditions

Interventions

DRUG

Everolimus (Afinitor) tablets

Everolimus administered orally once daily in continuous treatment. Phase Ib dose levels include 5 mg/day, 7.5 mg/day, and 10 mg/day using a standard 3+3 dose-escalation design. Phase II participants will receive everolimus at the RP2D determined in Phase Ib.

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Principal Investigators

  • Xiangxing Kong · Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2026-12-31
Completion
2028-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07435584 on ClinicalTrials.gov